Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	Other	CDR0000450846 CAN-NCIC-IND165, ONCOGENEX-OGX-011-03, FHCRC-6084, UWCC-UW-6084, UWCC-06-0499-H/D, NCT00258388

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. OGX-011 may help docetaxel and prednisone kill more tumor cells by making tumor cells less resistant to the drugs.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone with or without OGX-011 works in treating patients with recurrent or metastatic prostate cancer that did not respond to previous hormone therapy.

Further Study Information

OBJECTIVES:

Primary

• Determine the efficacy, in terms of prostate-specific antigen response, of docetaxel and prednisone with or without OGX-011 in patients with hormone-refractory locally recurrent or metastatic prostate cancer.

Secondary

• Determine the objective response rate and duration in patients treated with these regimens.

• Determine the safety and toxic effects of these regimens in these patients.

• Determine the overall and progression-free survival of patients treated with these regimens.

OUTLINE: This is a multicenter, randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive a loading dose of OGX-011 IV over 2 hours on days -7, -5, and -3. Patients then receive OGX-011 IV over 2 hours on days 1, 8, and 15, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Metastatic or locally recurrent disease

• Not curable with standard therapy

• Systemic chemotherapy is indicated, due to disease progression while receiving androgen-ablative therapy (i.e., hormone-refractory disease)

• Disease progression is defined as development of new metastatic lesions OR ≥ 2 consecutive rises in prostate-specific antigen (PSA) over a reference value

• Androgen ablative therapy must have included either medical or surgical castration

• Castrate level of testosterone (≤ 1.7 nmol/L) required if treated with medical androgen ablation

• Patients with documented disease progression while on peripheral antiandrogens must also have documented PSA progression after stopping antiandrogens

• PSA ≥ 5 ng/mL

• No known CNS metastases

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• No known bleeding disorder

Hepatic

• PT and PTT or INR normal

• Bilirubin normal

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No significant cardiac dysfunction

Other

• Fertile patients must use effective contraception

• No pre-existing peripheral neuropathy ≥ grade 2

• No active, uncontrolled infection

• No significant neurological disorder that would preclude study compliance

• No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy except estramustine and recovered

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• At least 4 weeks since prior antiandrogens (6 weeks for bicalutamide)

• Luteinizing hormone-releasing hormone (LHRH) agonist therapy must be continued* or restarted* during study treatment to maintain castrate levels of testosterone NOTE: *For patients receiving LHRH agonist therapy prior to study entry

Radiotherapy

• At least 4 weeks since prior external beam radiotherapy except low-dose, nonmyelosuppressive radiotherapy

• Must have had less than 25% of marrow irradiated

• No prior strontium chloride Sr 89

• No concurrent radiotherapy except low-dose, nonmyelosuppressive, palliative radiotherapy

Surgery

• At least 2 weeks since prior major surgery

Other

• At least 4 weeks since prior investigational agent

• At least 4 weeks since prior anticancer therapy

• No concurrent therapeutic anticoagulants except low-dose oral anticoagulants (i.e., 1 mg warfarin) or low molecular weight heparin

• No other concurrent investigational agents

• No other concurrent cytotoxic therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

NCIC-Clinical Trials Group

Kim N. Chi

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00258388
Information obtained from ClinicalTrials.gov on October 06, 2009

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